Collin MacNee ISO 9001 2015

Technical update on
ISO 9001:2015
Colin MacNee
Duncan MacNee Limited
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A Free sample June 2013from www.pptbackgrounds.fsnet.co.uk 2012, 2013 Duncan MacNee Limited 1
Caveat
The views expressed are my own and do not represent
BSI
CQI
IAF
IBM
IRCA
ISO
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Content
What is the process for updating ISO standards?
What are the stages
Who is involved
What is the current situation?

Background:1994, 2000 and 2008 revisions, User Surveys and QMPs
The ISO 9001:2015 Project plan, what we have achieved and what we have still to do
Current major revisions of ISO 9001, ISO 14001 and ISO 27001 (Reference to Annex SL)
How IRCA auditors influence the development?

When to contribute
How to contribute
What ISO 9001:2015 could look like?

Annex SL plus possible changes
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ISO Development Process 1 of 3
The ISO/IEC Directives Part 1 and Consolidated ISO

Supplement1 describes in detail the following stages:
1. Preliminary - Preliminary work item (PWI)

2. Proposal - New work item proposal (NP or NWIP)
3. Preparatory working draft(s) (WD)
4. Committee committee draft(s) (CD)
5. Enquiry draft international standard (DIS)
6. Approval final draft international standard (FDIS)
7. Publication international standard (IS)
1 Third edition, 2012 (based on the ninth edition of the ISO/IEC Directives, Part 1)
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Who will receive the documents?
Member bodies. E.g. JISC (Japanese Industrial Standards Committee)

Participating Countries: 73
Observing Countries: 16
Internal liaison to SC 2 (ISO: 8, IEC: 3)

External liaison to SC 2 (21)
ALL of the above are allowed to comment.
ONLY member bodies are allowed to vote.
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Voting
CD: 2/3 positive of total of member bodies voting

DIS: 2/3 positive AND not more than negative of total of member
bodies voting
FDIS: 2/3 positive AND not more than negative of total of
member bodies voting
Not counted in the total vote:

Abstentions
Negative votes without technical justification
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Current Situation
Background
1994, 2000 and 2008 revisions
User Surveys
Quality Management Principles (QMPs)
The ISO 9001:2015 Project plan

What we have achieved
What we have still to do
3 major ISO MSSs in development all using Annex SL

ISO/IEC 27001 (expected later this year)
ISO 14001 (expected early 2015)
ISO 9001 (expected late 2015)
ISO 22301:2012 developed using an early draft
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ISO/CD 9001
2013
Jan Mar May Jul Sep Nov
Feb Apr Jun Aug Oct Dec
CD ballot opens: June 2013

CD ballot closes: August 2013
It is standard practice for the CD to be distributed only to

member body mirror committees. However, some member
bodies may distribute the CD to the public (free or for sale)
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ISO/DIS 9001
2014
DIS ballot opens: April 2014

DIS ballot closes: August 2014
It is standard practice for the DIS to be distributed to members

of the public (free or for sale). Some member bodies provide
electronic tools for viewing and commenting on the DIS.
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ISO/FDIS 9001
2015
FDIS ballot opens: July 2015 ISO 9001 published:

FDIS ballot closes: August 2015 September 2015
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MSS High Level Structure 1 of 3
Introduction 4. Context of the organization
1. Scope 5. Leadership
2. Normative references 6. Planning
3. Terms and definition 7. Support
8. Operation
9. Performance evaluation
10. Improvement
Appendix
Bibliography
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4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the XXX management system
4.4 XXX management system
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organization roles, responsibilities and authorities
6. Planning
6.1 Actions to address risks and opportunities
6.2 XXX objectives and planning to achieve them
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7. Support 8. Operation
7.1 Resources 8.1 Operational planning and control
7.2 Competence
7.3 Awareness 9. Performance evaluation
7.4 Communication 9.1 Monitoring, measurement, analysis and
7.5 Documented information evaluation
7.5.1 General 9.2 Internal audit
7.5.2 Creating and updating 9.3 Management review
7.5.3 Control of documented information
10. Improvement
10.1 Nonconformity and corrective action
10.2 Continual improvement
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MSS Common Terms and
Definitions
Organization Process
Interested party (preferred term) Performance
Stakeholder (admitted term) Outsource (verb)
Requirement Monitoring
Management system Measurement
Top management Audit
Effectiveness Conformity
Policy Nonconformity
Objective Correction
Risk Corrective action
Competence Continual improvement
Documented information
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Possible ISO 9001:2015 *
1 of 3
4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organization roles, responsibilities and authorities
6. Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
*Note: This structure is based on a early draft of ISO CD 9001:2015

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2 of 3
7. Support 8. Operation
7.1 Resources 8.1 Operational planning and control
7.1.1 General
7.1.2 Infrastructure 9. Performance evaluation
7.1.3 Process environment
9.1 Monitoring, measurement, analysis and
7.1.4 Monitoring and measuring devices
evaluation
7.1.5 Knowledge
9.1.1 General
7.2 Competence 9.1.2 Customer satisfaction
7.3 Awareness 9.1.3 Analysis and evaluation of data
7.4 Communication 9.2 Internal audit
7.5 Documented information 9.3 Management review
7.5.1 General
7.5.2 Creating and updating 10. Improvement
7.5.3 Control of documented information 10.1 Nonconformity and corrective action
10.2 Continual improvement

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3 of 3
8. Operation 8.5 Development of goods and services

8.1 Operational planning and control 8.5.1 Development processes
8.2 Determination of market needs and 8.5.2 Development controls
interactions with customers 8.5.3 Development transfer
8.2.1 General 8.6 Realization of goods and services
8.2.2 Determination of requirements related to 8.6.1 Control of production of goods and
the goods and services provision of services
8.2.3 Review of requirements related to the 8.6.2 Identification and traceability
goods and services 8.6.3 Property belonging to customers or
8.2.4 Customer communication external providers
8.3 Operational planning 8.6.4 Preservation of goods or services
8.6.5 Post delivery activities
8.4 Control of external provision of goods
and services 8.6.6 Control of changes
8.4.1 General 8.7 Release of goods or services
8.4.2 Type and extent of control of external 8.8 Nonconforming goods and services
provision
8.4.3 Documented information for external
providers

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Thank You
Any Questions?
A Free sample
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Technical update on

What is the current situation?

How IRCA auditors influence the development?

What ISO 9001:2015 could look like?

The ISO/IEC Directives Part 1 and Consolidated ISO

1. Preliminary - Preliminary work item (PWI)

Who will receive the documents?

Member bodies. E.g. JISC (Japanese Industrial Standards Committee)

Internal liaison to SC 2 (ISO: 8, IEC: 3)

ALL of the above are allowed to comment.

ONLY member bodies are allowed to vote.

CD: 2/3 positive of total of member bodies voting

Not counted in the total vote:

The ISO 9001:2015 Project plan

3 major ISO MSSs in development all using Annex SL

ISO 22301:2012 developed using an early draft

Feb Apr Jun Aug Oct Dec

CD ballot opens: June 2013

It is standard practice for the CD to be distributed only to

Feb Apr Jun Aug Oct Dec

DIS ballot opens: April 2014

It is standard practice for the DIS to be distributed to members

Jan Mar May Jul Sep Nov

Feb Apr Jun Aug Oct Dec

FDIS ballot opens: July 2015 ISO 9001 published:

Introduction 4. Context of the organization

2. Normative references 6. Planning

3. Terms and definition 7. Support

*Note: This structure is based on a early draft of ISO CD 9001:2015

*Note: This structure is based on a early draft of ISO CD 9001:2015

8. Operation 8.5 Development of goods and services

*Note: This structure is based on a early draft of ISO CD 9001:2015

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